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Trial record 1 of 1 for:    obi-833
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Trial of Active Immunotherapy With OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal or Breast Cancer Subjects

This study is currently recruiting participants.
Verified December 2016 by OBI Pharma, Inc
Sponsor:
ClinicalTrials.gov Identifier:
NCT02310464
First Posted: December 8, 2014
Last Update Posted: December 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
OBI Pharma, Inc
  Purpose
The primary purpose of the clinical trial is to investigate safety and tolerability of escalating doses of OBI-833/OBI-821 in subjects with metastatic incurable solid tumors, such as gastric, lung,colorectal or breast cancer. Meanwhile, the tumor response and humoral immune responses, i.e.,anti-Globo H IgG and IgM production following administration of OBI-833/OBI-821 will be assessed as the secondary objective of this study.

Condition Intervention Phase
Metastatic Gastric Cancer Metastatic Breast Cancer Metastatic Colorectal Cancer Metastatic Lung Cancer Drug: OBI-833/OBI-821 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Assess the Safety and Tolerability of Active Immunotherapy With Escalating Doses of OBI-833/OBI-821 (Globo H-CRM197/OBI-821) in Subjects With Advanced/Metastatic Gastric, Lung, Colorectal or Breast Cancer

Resource links provided by NLM:


Further study details as provided by OBI Pharma, Inc:

Primary Outcome Measures:
  • Safety and tolerability assessed by adverse events, changes in laboratory values, and changes in vital signs. [ Time Frame: 36 weeks ]

Estimated Enrollment: 58
Study Start Date: December 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OBI-833/OBI-821 (Globo H-CRM197/Adjuvant)
Single Arm. Each subject will be given a total of 10 doses of OBI-833/OBI-821 subcutaneously at weeks 1,2,3,4,6,8,12,16,20,and 24 (Visits 1,2,3,4,5,6,7,8,9 and 10, respectively). Post treatment, subjects will be continually evaluated for safety and immune response every 4 weeks until the end of study, which is 12 weeks after the last dose, i.e., week 36. Subsequently, subjects will be followed for survival every 8 weeks up to 12 months after the end of study.
Drug: OBI-833/OBI-821

Detailed Description:
The First-In-Human clinical trial will evaluate the safety and tolerability of three doses of OBI-833 (10,30 and 100μg) along with a fixed dose of 100μg OBI-821 adjuvant in a small number of patients (N=26) with late stage gastric, colorectal, breast and lung cancers. Patients will receive a total 10 doses subcutaneously over 24 weeks, and will be evaluated for safety and immune response during the 24 week treatment period and subsequently observed for additional 12 weeks post-treatment. In addition to the standard battery of safety tests, evaluations will also include immunological response, tumor markers and clinical endpoints such as disease or progression free survival (RECIST 1.1).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects ≥21 years of age
  2. Histologically or cytologically confirmed diagnosis of gastric, lung, colorectal or breast cancer on file
  3. Subjects with recurrent or metastatic incurable disease that failed to respond to at least one line of anticancer standard therapy and for which standard treatment is no longer effective or tolerable.
  4. Measurable disease (i.e., present with at least one measurable lesion per RECIST, version 1.1.
  5. Performance status: ECOG ≤ 1
  6. Organ Function Requirements - Subjects must have adequate organ functions as defined below:

    AST/ALT ≤ 3X ULN (upper limit of normal) AST/ALT ≤ 5X ULN [with underlying liver metastasis] Total bilirubin ≤ 2.0 X ULN Serum creatinine ≤ 1.5X ULN ANC ≥ 1500 /µL Platelets > 100,000/µL

  7. Subjects of child-bearing potential must agree to use acceptable contraceptive methods during treatment and until the end of study. Subject not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in study. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.
  8. Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.

Exclusion Criteria:

  1. Patients who have not received standard chemotherapy, hormonal or targeted therapy for their underlying advanced/metastatic cancer.
  2. Subjects who are pregnant or breast-feeding at entry.
  3. Subjects with splenectomy.
  4. Subjects with known or clinically manifest, symptomatic CNS metastases.
  5. Subjects with HIV infection, active hepatitis B infection or active hepatitis C infection.
  6. Subjects with any autoimmune disorders requiring iv/oral steroids or immunosuppressive or immunomodulatory therapies.

    - e.g., Type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis, Grave's disease, Hashimoto's thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, etc.

  7. Subjects with any known uncontrolled inter-current illness including ongoing or active infections, symptomatic congestive heart failure (NYHA>2), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  8. Subjects with any of the following MEDICATIONS within 4 weeks prior to IP treatment, except permitted therapies as listed in section 7.1:

    • Chemotherapeutic Agent
    • Immunotherapy [mAbs, Interferons, Cytokines (except GCSF)]
    • Immunosuppressants (e.g., cyclosporin, rapamycin, tacrolimus, rituximab, alemtuzumab, natalizumab, etc.).
    • IV/oral steroids except single prophylactic use in CT/MRI scan or other one-time use in approved indications.
    • Another investigational drug
  9. Subjects with pleural effusions and/or ascites, due to malignancy, requiring paracentesis every 2 weeks or more frequently.
  10. Subjects with any known severe allergies (e.g., anaphylaxis) to any active or inactive ingredients in the study drugs.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310464


Contacts
Contact: Liz Yu +886-2-27866589 ext 208 lyu@obipharma.com

Locations
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States, 44718
Contact: Nashat Nashat, Dr.         
Principal Investigator: Nashat Nashat, Dr.         
United States, Texas
Mary Crowley Cancer Research Center Recruiting
Dallas, Texas, United States, 75230
Contact: John Nemunaitis, Dr.         
Principal Investigator: John Nemunaitis, Dr.         
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Chia-Chi Lin, Dr.         
Principal Investigator: Chia-Chi Lin, Dr.         
Taipei Medical University Hospital Recruiting
Taipei, Taiwan, 11031
Contact: Her-Shyong Shiah, Dr.         
Sponsors and Collaborators
OBI Pharma, Inc
Investigators
Principal Investigator: Chia-Chi Lin, Dr. National Taiwan University Hospital
Principal Investigator: Nashat Gabrail, Dr. Gabrail Cancer Center Research
Principal Investigator: John Nemunaitis, Dr. Mary Crowley Cancer Research Center
Principal Investigator: Her-Shyong Shiah, Dr. Taipei Medical Center
  More Information

Responsible Party: OBI Pharma, Inc
ClinicalTrials.gov Identifier: NCT02310464     History of Changes
Other Study ID Numbers: OBI-833-001
First Submitted: December 2, 2014
First Posted: December 8, 2014
Last Update Posted: December 2, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Stomach Neoplasms
Lung Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases